1. Field of the Invention
The invention relates to the field of medical sciences and in particular to devices used to facilitate femoral vascular stanching.
2. Description of The Prior Art
During cardiac catheterization and angiography, it is necessary to obtain access to the heart and other major body arteries and veins in order to visualize them with radioopaque materials. One of of the preferred sites for such major vascular access is through the major femoral arteries and veins in the groin. The typical prior art procedure is to insert appropriate tubing into the femoral vessels through a small incision in the groin. The tube is later removed leaving a perforation in the femoral artery and/or vein. Normal blood clotting is utilized to render the repaired incision and vascular perforation blood-tight. Manual pressure is applied to the incision site for at least twenty minutes following removal of the tube from the artery or vein to allow for a clot of strength sufficient to withstand the arterial pressure of 120-180 mm Hg. Normally, manual pressure by trained medical personnel is sufficient to successfully clot the femoral arterial or venous perforation site and stanch the blood flow. However, despite this twenty minute time period the clot is soft and can be easily disrupted. Therefore, for some period of time thereafter it is advantageous to maintain a compressive force on the femoral puncture site to insure that it remains stanched.
The typical prior art procedure is to manufacture a thick pad of gauze which is placed over the site and taped securely to the patient's hip and groin in order to secure it in place and to maintain some compressive force over the incision site. The compressive force is generated and maintained by virtue of the bulk of the folded gauze pad pressed downwardly by the adhesive tape which is laid over the pad and which is attached on either side of the incision site to adjacent portions of the hip and groin.
Pursuant to the normal usage of such gauze and adhesive tape bandages, all contiguous areas of the incision site must be shaved and coated with an antiseptic and/or skin toughening agent. Approximately twenty-four hours later the bandages can be removed. However, a considerable amount of the body area in the area of the hip and groin is taped so that removal of the bandages is often an unpleasant and uncomfortable experience for the patient. Often some abrasion or skin tearing results and at the very least, there is some infliction of sharp temporary pain since the body area has been traumatized and is tender. Further, in many cases, patients may develop an allergic reaction to the adhesive or antiseptic applied to the body causing further tenderness and pain upon removal of the tape.
Further, if in the event that movement by the patient causes the blood clot to be damaged or dislodged, it may be necessary to reapply manual pressure and apply a new compression pad to the patient. In such a case, the old bandage must be quickly removed and the new bandage applied with the result that the patient may be subjected to the pain and discomfort of bandaging and unbandaging several times during the initial convalescence.
To avoid each of these drawbacks, the prior art has devised a groin compression device known as the Colapinto compression device, named after its creator in Canada. The Colapinto compression device is manufactured and sold under that name by Cook of Bloomington, Indiana.
FIG. 1 is a frontal view of a patient bearing the prior art Colapinto device, generally denoted by reference numeral 10. FIG. 2 is a side view of the patient wearing the Colapinto device of FIG. 1. Briefly, the Colapinto device 10 includes a groin pad 12 which has a bi-lobed shape. A waist strap 14 is sewn at end 16 to groin pad 12 and wraps around the lower hips below the hip points, across the upper part of the buttocks and around the buttocks to the other side of groin pad 12 where strap 14 is attached at end 18 by means of a Velcro attachment provided to end 18 of strap 14 and the corresponding proximate portion of groin pad 12. Sewn to the lower center portion of groin pad 12 are two stabilizing straps 20 which are drawn between the legs and around the lower portion of each buttock and attached at end 22 to a Velcro fastener on strap 14 to the middle of the side of the hip as depicted in FIG. 2 below the hip point. The purpose and function of straps 20 are to provide only stabilization to groin pad 12 and they do not add in any material way to the compressive force applied by groin pad 12 to the underlying femoral arterial or venous incision site.
Shown in dotted outline in the left groin region under groin pad 12 in FIG. 1 is a styrofoam pellet in the shape of a sector of a sphere with a flattened pole. The diameter or cord of the sector is approximately 27/8" with the thickness of the pellet from the flattened pole face to the base defined by the section is approximately one inch. Pellet 24 therefore is roughly hemispherical with a flattened pole face of approximately an inch across and serves to replace the equivalent amount of folded gauze to define the pressure point against the femoral arterial or venous incision.
Two material characteristics of the Colapinto compression device should be immediately noted. Firstly, the compressive force applied to pellet 24 by device 10 is substantially if not entirely created by virtue of the tension of waist strap 14. Pellet 24 is disposed on the relatively flattened front portion of the groin and the amount of downward compressive force which can be developed on pellet 24 by virtue of the tension of waist strap 14 is significantly limited.
Secondly, the Colapinto compression device can be used only either on the left or on the right femoral arterial site. For example, in the depiction of FIG. 1, if application to the left femoral arterial site was desired, pellet 24, which is attached by means of a Velcro fastening device to the back of groin pad 12, can be shifted to the left side of groin pad 12 and the entire groin pad similarly shifted to the left to position pellet 24 over the arterial site. The size and extent of groin pad 12 of the Colapinto device is not sufficient to allow simultaneous application to both left and right femoral arterial sites. In any case, it is unlikely that sufficient compressive force could be developed if two pellets were positioned underneath groin pad 12.
Therefore, what is needed is a compression device which overcomes each of the defects of the prior art and in particular which can apply a large and adjustable compression force to either the left or the right femoral vascular sites, or to both.